Policy & Regulation
International Clinical Trial Utilises Personal Genome Diagnostics' Liquid Biopsy Assay to Enroll Patients based on POLE/POLD1 status as a Predictor of Response to Immunotherapy
11 October 2018 - - US-based cancer genomics and liquid biopsy specialist Personal Genome Diagnostics, Inc.'s non-invasive, pan-cancer plasma assay is being used in a new clinical trial, Nivolumab, Ipilimumab in Patients With Hyper Mutated Cancers Detected in Blood (NIMBLe), led by the Cancer Research Institute and Canadian Cancer Trials Group, the company said.

In part, the trial will explore the use of PGDx's liquid biopsy assay to confirm POLE and POLD1 mutations in solid tumors and to investigate whether those tumor types are responsive to immunotherapy.

The study will evaluate the efficacy and safety of nivolumab (anti-PD-1) alone and in combination with ipilimumab (anti-CTLA-4) in patients with POLE and POLD1 mutations and will collect both blood and tumor tissue samples from patients to look at correlation between mutations detected in a tumor tissue sample and those detected from a blood test.

The study will open in centers in the US and Canada soon. Nivolumab and ipilimumab have well characterized safety profiles.

PGDx provides solutions from biomarker discovery to companion diagnostic development through its CAP/CLIA certified laboratory and is developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide.

Personal Genome Diagnostics is developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies.
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